Systemic Effects of Aprotinin During Cardiac Surgery/ Long Term Death Rates

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Syracuse,
New York13210

Purpose:

The dept. of Anesthesiology currently has a database of subjects whom had surgery and
received either Aprotinin or Amicar in the OR. The current viewpoint is that Aprotinin is
more harmful than Amicard. In an effort to see what the long term outcomes were for subjects
whom had surgery here at Upstate, it was decided to look at long term death rates to see if
any differences. A student t-test will be used to determine statistical significance where a
p value of <0.05 will be deemed significant. Using data from 462 subjects that had undergone
cardiac surgery at SUNY Upstate Medical University, CABG only and the long term mortality
rate from the Mangano, et.al. publications, the unadjusted mortality for the two drugs are
Aprotinin 5.4% and Amicar 1.2%. A power analysis was performed using the hospital mortality
rates of 5.4% and 1.2% with the sample size in the propensity data and a p-value of 0.05.
The result was a power of 81.7%.

Study summary:

Charts for 462 subjects will be reviewed from 2002-2005 based on the surgery performed. From
each chart, the subject name, date of birth,and social security number will be recorded
along with the state of residence and year of surgery. This information will be transferred
to a CD that is encrypted and password protected. The CD will be sent via FedEx overnight to
the Center for Disease Control(CDC), National Death Registry. The CDC will use the
information on the CD to extract death outcomes for each subject's information provided.
Once all information is complete, the CDC will transfer on to a CD that is encrypted and
password protected and return to our office via FexEx overnight. The information on the CD
will then be used to determine what the long term death rates were for subjects here at SUNY
Upstate Medical University and stored in an anonymous database. Once the information is
verified as accurate, the CD will be destroyed and no identifying information will be kept.
The CDC will also destroy the information after 60 days, with no links to the identifying
information.

Criteria:

Inclusion Criteria:
- Subjects must be 18 years of age or older
- Subjects must have received either Aprotinin or Amicar during cardiac surgery
Exclusion Criteria:
- Cardiac surgery and did not receive Aprotinin or Amicar

NCT ID:

NCT00617955

Primary Contact:

Principal InvestigatorNancy A Nussmeier, MDState University of New York - Upstate Medical University

Backup Contact:

N/A

Location Contact:

Syracuse, New York 13210United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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